NCT02152852

Brief Summary

The purpose of this study is to test the hypotheses that CHWs providing in-home support for self-management of type 2 diabetes, resources for diabetes, and assistance in effective linkage and communication with medical providers will: (1) improve HbA1c (primary outcome) and secondary outcomes including lipids, blood pressure, health care utilization, and health-related quality of life; (2) improve diabetes self-management, including self-efficacy, physical activity, nutrition, and medication adherence; and (3) be cost-effective and feasible.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

3.4 years

First QC Date

May 23, 2014

Last Update Submit

April 12, 2017

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Improvement in HbA1c

    HbA1c will be assessed at baseline and then again at 12 months.

    One Year

Secondary Outcomes (4)

  • Improvement in lipids

    One Year

  • Improvement in blood pressure

    One Year

  • Healthcare Utilization

    One Year

  • Physical and mental functioning

    One year

Study Arms (2)

Community Health Worker Intervention

EXPERIMENTAL

Community Health Worker Intervention-home visits from community health workers providing education and support for self-management of type 2 diabetes, resources for diabetes control, and assistance in effective communication with medical providers

Behavioral: Community Health Worker Intervention

Usual Care Control Group

NO INTERVENTION

Usual Care Control Group- Usual care is defined as services received by participants in the absence of the intervention plus information about community resources that support diabetes self-management (such as classes and support groups) and educational pamphlets.

Interventions

Community Health Worker InterventionBEHAVIORAL

For the intervention group, a trained Community Health Worker (CHW) will provide education, support and service coordination through in-home visits. The CHW will first make an in-home assessment visit. At the assessment visit, the participant has the opportunity to ask questions and sign written consent. During this visit, the CHW assesses the participant's history with diabetes, medication adherence, self-management activities, healthcare utilization and will administer a finger stick blood test for HbA1c and a full lipid panel. After enrollment, the participant receives up to five follow-up educational visits 0.5, 1.5, 3.5, 7 and 10 months later. In addition to scheduled visits, the CHWs work with their participants on an as-needed basis via telephone, or additional home visits.

Community Health Worker Intervention

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes and HbA1c of 8.0% or greater
  • Household income less than 250% of the federal poverty level
  • Residence within target area of King County, Washington
  • Age 30-70 years.
  • Primary language spoken by participant is English or Spanish

You may not qualify if:

  • Type 1 diabetes
  • Pregnant
  • Unable to provide informed consent
  • End-stage renal disease (ESRD), dementia, or a terminal illness
  • Plans to move within the next two years or is homeless
  • Other mental or physical disability making it impossible to participate in the protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Karin Nelson, MD, MSHS

    VA Puget Sound

    PRINCIPAL INVESTIGATOR

  • James Krieger, MD, MPH

    Public Health Seattle King County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 2, 2014

Study Start

November 1, 2011

Primary Completion

April 1, 2015

Study Completion

December 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04